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Daré Bioscience Announces Publication of DARE-BV1 Proof of Concept Study for the Treatment of Bacterial Vaginosis
DARE-BV1 is an investigational, proprietary thermosetting hydrogel formulation of clindamycin phosphate 2% for one-time vaginal administration in patients
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"DARE-BV1 is an investigational, proprietary thermosetting hydrogel formulation of clindamycin phosphate 2% for one-time vaginal administration in patients diagnosed with bacterial vaginosis\nSAN DIEGO, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced the publication of a proof of concept study of DARE-BV1 in Clinical and Experimental Obstetrics & Gynecology, an international journal focused on publication of high quality scientific research related to obstetrics and gynecology and women’s health. DARE-BV1 is a novel thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% that is being evaluated as a one-time vaginally administered treatment for bacterial vaginosis (BV). \n The publication, entitled “Proof of concept study of a novel bioadhesive clindamycin phosphate 2% vaginal gel to treat bacterial vaginosis,” reported that a single dose of the study drug, now known as DARE-BV1, administered to 30 patients diagnosed with bacterial vaginosis showed a meaningful clinical cure rate of 86% in evaluable patients at the test-of cure visit. Clinical cure was defined as the resolution of specified clinical signs and symptoms of bacterial vaginosis that were present at the time of enrollment in the study. “This proof of concept study suggests that DARE-BV1 has the potential to be a highly effective treatment option for bacterial vaginosis, the most common cause of vaginal symptoms among women,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “At the test-of-cure visit 7 to 14 days after dosing, 86% of the evaluable patients in the study were clinically cured of their bacterial vaginosis and 96% of those women remained clinically cured at the follow-up visit 21 to 30 days after dosing. There were no reports of adverse reactions to DARE-BV1 over the duration of the study.” Bacterial vaginosis is the leading cause of vaginitis worldwide and is estimated to affect more than 21 million women in the United States.1,2 It is estimated that bacterial vaginosis is present in at least 15% of the sexually active population3 and is associated with a variety of serious health issues including preterm birth, pelvic inflammatory disease, increased susceptibility to sexual transmitted infections (including HIV), and other chronic health probl...